Effectiveness of Somatostatin Analogues in patients with Gastric antral vascular ectasia and symptomatic gastrointestinal bleeding: SAGAVE-trial
- Conditions
- 1) Gastric Antral Vascular Ectasia. 2) Watermelon stomach.10017959
- Registration Number
- NL-OMON49336
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 14
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Patients older than 18 years with written informed consent.
- Endoscopic diagnosis of GAVE, confirmed within the last 12 months
- Endoscopic refractory: at least 1 endoscopic APC, RFA, or other treatment
modality performed within 12 months OR unable to receive endoscopic treatment
(e.g. Pacemaker, ICD) OR patient has repeatedly indicated that they do not want
endoscopic treatment OR treating physician had deemed further endoscopic
treatment not relevant
- Substantial transfusion dependency: at least 4 blood units and / or
intravenous iron (per 500mg) in the 6 months prior to study inclusion with:
* At least one serum ferritin below < 30 ug/l within the last 6 months
requiring iron infusion above or equal to 1 g and/or
* Haemoglobin below 5.6 mmol/l (9.0 g/dl) or are in need of transfusions due to
anaemia related symptoms within the last 6 months requiring red blood cell
transfusion above.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Insulinoma
- Uncontrolled diabetes mellitus as defined by HbA1c >64 mmol/ml, despite
adequate therapy,
- Symptomatic cholecystolithiasis (possible side effect octreotide),
- Pregnancy or nursing women or women have a pregnancy wish during the study
period.
- Liver cirrhosis Child-Pugh C
- Chronic or acute pancreatitis
- Patients with other plausible causes of gastrointestinal bleeding (e.g.
severe portal hypertensive gastropathy and oesophageal varices which have
recently bled)
- Bradycardia (heart rate below 50)*
- Hypersensitivity to the active ingredient (octreotide) or to auxiliary
materials of the study medication
- Severe diseases / comorbidities with a life expectancy < 1 year
- Use of other anti-angiogenic drug treatment (thalidomide and / or bevacizumab)
*If a patient has a heart rate below 60 and uses cardiovascular medication that
affect the heart rate (e.g. beta blockers and calcium channel blockers) the
prescribing specialist (or another competent specialist) will be consulted
about the possibility to adjust the dose of these medicines. Patients with a
heartrate below 50 (despite dose adjustments) will be excluded from
participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The absolute and percentage difference in the mean / median number of<br /><br>intravenous (IV) iron infusions and the mean / median number of red blood cell<br /><br>(RBC) transfusions that was given between the baseline period (26 weeks prior<br /><br>to study inclusion) and the treatment study period (of 26 weeks) and the<br /><br>percentage of patients with a succesful response, defined as a decrease of >=<br /><br>50% in the number of IV iron infusions and / or number of RBC transfusions.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The absolute mean / median difference and the percentage mean and median<br /><br>difference between the baseline period (26 weeks prior to study inclusion) and<br /><br>the treatment study period (26 weeks) in:<br /><br>- Number of endoscopic treatments<br /><br>- Patient reported outcome measures (PROMS): which include quality of life<br /><br>(measured by the SF-36) and level of fatigue (measured by the multidimensional<br /><br>fatigue inventory (MFI)-20)<br /><br><br /><br>The absolute mean / median difference and the percentage mean / median<br /><br>difference at baseline (< 7 days before inclusion) between and after 4 weeks,<br /><br>12 weeks, and 26 weeks of the study period in the value of:<br /><br>- Hemoglobin and ferritin levels<br /><br><br /><br>The absolute number of (S)AE's reported during the treatment study period (of<br /><br>26 weeks) and the absolute number of patients and percentage of patients that<br /><br>reported at least one (S)AE. </p><br>